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DSCSA ImplementationPanel Discussion
Chaired by Mr. Scott Mooney, Vice President Distribution Operations – Supply Chain Assurance, McKesson Pharmaceutical Mr. Christopher Reed, Global Operations Manager – GDSN, Johnson & Johnson Supply ChainMr. Thomas McHugh, Senior Strategeist Supply Chain & Technology, CVS HealthMr. Jeffrey Denton, IT Global Secure Supply Chain, Amerisourcebergen Corporation
18 October 2017
DSCSA ImplementationManufacturer Perspective
Christopher Reed Supply Chain VisibilityOctober 2017
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• Global Leader in Health Care
• More than 265 Operating Companies in 60 Countries
• Selling Products in More than 175 Countries
Johnson & JohnsonGlobal Presence
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Agenda
• Why Serialization?
• Effectively Operationalizing Your Serialization Program
• Challenges and Lessons Learned
• Next Steps and Interoperability
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Why Are We Serializing and Track & Tracing Our Products?Counterfeit and diverted products are a global problem
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Timeline to Comply
DSCSAImplementation Timeline
November 2013Congress enacts the DSCSA
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
January 2015Manufacturers send and distributors receive Lot data
2017/2018Manufacturersserialize products
2018Repackagersserialize
2019Distributors traceability
2020Pharmacytraceability
2023Unit level traceabilityFirst customer
pilot in 2013
JJSC Initiates program in 2012
Expanding Customer ConnectivityHDA/Customer Pilots In 2016
Verification and Lot Level Tools
System to capture serial numbers goes-live in 2014
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Supply Chain with Track & Trace
12 serialized & aggregatedPREZISTA®
bottles in a case
261 cases to a pallet. Each case has the
parent serial number
Pallet is shipped(truck, boat, orairplane) to DC
DC where individual cases get pulled from the pallet, scanned and
shipped to Customer
Wholesaler Customerreceive products, scans every case and ships to pharmacies, hospitals,
etc.
Wholesaler ships productto pharmacies, hospitals, etc. They scan bar code
with serial number
Rx
PREZISTA®
Used to treat human immunodeficiency virus (HIV)
Regulatory mandates are demanding visibility of products from point of packaging to point of dispense
• Demand improved supply chain visibility
• What product? • Where has it been? • Where is it going? • How long has it been there?• What are the inventory levels?
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Effectively Operationalizing Your Serialization ProgramThe Johnson & Johnson Supply Chain Experience
Key Takeaways
• Regulations remain primary driver of serialization and traceability
• Interoperability relies on standards
• A multidisciplinary approach is a must have
• Workforce impact is significant
• Tremendous importance on master data and change management
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Interoperability And StandardsDevelopment and adoption of standards are critical
Standards Must Enable These Capabilities
GTINGLN
SSCC
UPC / EANDATAMATRIX/BAR
EPC / RFID
GDSNEDI
EPC / RFIDSource: GS1
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Interoperability And StandardsDevelopment and adoption of standards are critical
Internal/ External Standards and Guidelines are necessary to achieve and sustain end-to-end supply chain visibility
Product Identification and Traceability • Policy• Technical Standard• Standard Operating Procedures
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Collaboration Identifies Additional Business Value Opportunities
• Strengthens supply chain integrity
• Higher fidelity visibility enables efficiency improvements- Reducing counts and checks
- Reducing claims and credits
- Enhancing returns verification
• Communal standardizing of “best practices”
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Lessons LearnedOrganizing and sustaining a large, global initiative provides tremendous opportunities to learn and grow
• Agile
• Lead times
• Collaboration
• Communicate
• Utilization of partners
• Strategy and execution
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7 Billion Reasons to Care
Serialization and Traceability Benefits Patients and Consumers Around the Globe
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Christopher ReedSupply Chain Visibility
Johnson & Johnson Supply [email protected]
